Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

NCT ID: NCT05024292

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2027-04-30

Brief Summary

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To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.

Detailed Description

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For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rapid local ischemic postconditioning (RL-IPostC) group

RL-IPostC is performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.

rapid local ischemic postconditioning (RL-IPostC)

Intervention Type PROCEDURE

with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation

control group

no intervention was provided after successful reperfusion

No interventions assigned to this group

Interventions

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rapid local ischemic postconditioning (RL-IPostC)

with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,;
2. Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke;
3. Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;
4. Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital
5. The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt

Exclusion Criteria

1. Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;
2. Patients underwent rescue angioplasty or stenting after thrombectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhangzhou Municipal Hospital of Fujian Province

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yueqi Zhu

Associated dean of the radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yueqi Zhu, PhD

Role: STUDY_CHAIR

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Locations

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Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Site Status RECRUITING

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yueqi Zhu, PhD

Role: CONTACT

+86-21-18930177565

Facility Contacts

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Wenhuo Chen, MD

Role: primary

+86-596-2082950

Jiangshan Deng, PhD

Role: primary

02164369181

Other Identifiers

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2021MT

Identifier Type: -

Identifier Source: org_study_id

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